FDA.reportPublic FDA data

HELMUT ZEPF

Primary DI
EZPF85255020
Brand
HELMUT ZEPF
Company
Helmut Zepf Medizintechnik GmbH
Model
85.255.02
Catalog number
85.255.02
Device description
CUP, PROPHYLAXIS STORAGE BOX FOR 10 TITANIUM PINS
Published
2022-12-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
EHKCUP, PROPHYLAXIS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EHKCup, ProphylaxisDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
EZPF85255020PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Instrument transport trolley systemA combination of carts and/or portable containers designed for safe storage, handling, and transportation of reusable clinical instruments (typically endoscopes or surgical instruments) between the operating and central sterilization rooms. It typically consists of an instrument trolley (cart) with containers; smaller systems may consist of portable closed trays or boxes with gasket seals and/or filters.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+49742498880info@zepf-dental.com

Regulatory Flags#

DUNS number
320001431
Device count
1
Premarket exempt
true
Lot or batch
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
EZPF2423001G0HELMUT ZEPF24.230.01G24.230.01G2026-04-13
EZPF2423001GM50HELMUT ZEPF24.230.01GM524.230.01GM52026-04-13
EZPF2423103G0HELMUT ZEPF24.231.03G24.231.03G2026-04-13
EZPF2423105G0HELMUT ZEPF24.231.05G24.231.05G2026-04-13
EZPF2423105GM50HELMUT ZEPF24.231.05GM524.231.05GM52026-04-13
EZPF2423105L0HELMUT ZEPF24.231.05L24.231.05L2026-04-13
EZPF2423411G0HELMUT ZEPF24.234.11G24.234.11G2026-04-13
EZPF2423411GM50HELMUT ZEPF24.234.11GM524.234.11GM52026-04-13
EZPF2423415G0HELMUT ZEPF24.234.15G24.234.15G2026-04-13
EZPF2423507G0HELMUT ZEPF24.235.07G24.235.07G2026-04-13
EZPF2423507GM50HELMUT ZEPF24.235.07GM524.235.07GM52026-04-13
EZPF2423609G0HELMUT ZEPF24.236.09G24.236.09G2026-04-13
EZPF2423713G0HELMUT ZEPF24.237.13G24.237.13G2026-04-13
EZPF2423713GM50HELMUT ZEPF24.237.13GM524.237.13GM52026-04-13
EZPF2423717G0HELMUT ZEPF24.237.17G24.237.17G2026-04-13
EZPF2423803L0HELMUT ZEPF24.238.03L24.238.03L2026-04-13
EZPF2423804S0HELMUT ZEPF24.238.04S24.238.04S2026-04-13
EZPF2423804SD0HELMUT ZEPF24.238.04SD24.238.04SD2026-04-13
EZPF2423806HF0HELMUT ZEPF24.238.06HF24.238.06HF2026-04-13
EZPF2423823A0HELMUT ZEPF24.238.23A24.238.23A2026-04-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07897990300103PROPHY BRUSHESTDV DENTAL LTDAEHK2026-05-18
07897990300110PROPHY BRUSHESTDV DENTAL LTDAEHK2026-05-18
07897990300127PROPHY BRUSHESTDV DENTAL LTDAEHK2026-05-18
07897990300219PROPHY BRUSHESTDV DENTAL LTDAEHK2026-05-18
07897990300233PROPHY BRUSHESTDV DENTAL LTDAEHK2026-05-18
07897990300264PROPHY BRUSHESTDV DENTAL LTDAEHK2026-05-18
07897990300271PROPHY BRUSHESTDV DENTAL LTDAEHK2026-05-18
07897990300288PROPHY BRUSHESTDV DENTAL LTDAEHK2026-05-18
07897990300295PROPHY BRUSHESTDV DENTAL LTDAEHK2026-05-18
07897990300325PROPHY BRUSHESTDV DENTAL LTDAEHK2026-05-18
07897990300332PROPHY BRUSHESTDV DENTAL LTDAEHK2026-05-18
07897990301070PROPHY BRUSHESTDV DENTAL LTDAEHK2026-05-18
07897990301087PROPHY BRUSHESTDV DENTAL LTDAEHK2026-05-18
07897990301094PROPHY BRUSHESTDV DENTAL LTDAEHK2026-05-18
07897990301100PROPHY BRUSHESTDV DENTAL LTDAEHK2026-05-18
07897990301117PROPHY BRUSHESTDV DENTAL LTDAEHK2026-05-18
07897990301124PROPHY BRUSHESTDV DENTAL LTDAEHK2026-05-18
07897990301131PROPHY BRUSHESTDV DENTAL LTDAEHK2026-05-18
07897990301148PROPHY BRUSHESTDV DENTAL LTDAEHK2026-05-18
07897990399985PROPHY BRUSHESTDV DENTAL LTDAEHK2026-05-18
07897990399992PROPHY BRUSHESTDV DENTAL LTDAEHK2026-05-18
D2486058701Hager Prophy Brush Fine FlatHAGER WORLDWIDE, INC.EHK2026-05-12
D2486058711Hager Prophy Brush Regular FlatHAGER WORLDWIDE, INC.EHK2026-05-12
TQ26PA25523S1Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EHK2024-10-31
TQ26PA25525F1Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EHK2024-10-31
00302730003246Young DentalYOUNG DENTAL MANUFACTURING I, LLCEHK2024-09-27
00302730003253Young DentalYOUNG DENTAL MANUFACTURING I, LLCEHK2024-09-27
00302730003260Young DentalYOUNG DENTAL MANUFACTURING I, LLCEHK2024-09-27
00302730003277Young DentalYOUNG DENTAL MANUFACTURING I, LLCEHK2024-09-27
D686200327713Waterpik Professional Dental Products Sample PackWATER PIK, INC.EHK2023-08-24